- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01564342
Tap Water Versus Normal Saline for Wound Irrigation
A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management
This study is designed to compare the infection rates in wounds irrigated with sterile normal saline to those irrigated with chlorinated tap water. The hypothesis is that the wound infection rate subsequent to irrigation with tap water is not significantly different than the infection rate for wounds irrigated with sterile normal saline.
Inclusion criteria are patients older than 1-year of age who present to the emergency department with a soft-tissue laceration requiring repair. Exclusion criteria include patients with any underlying immunocompromising illness, current use of antibiotics, puncture or bite wounds, underlying tendon or bone involvement, or wounds more than nine hours old.
Patients are randomized to have their wounds irrigated either with tap water or sterile normal saline prior to closure, controlling for the volume and irrigation method used. Structured follow-up is completed at 48 hours and 30 days to determine the presence of infection.
The primary outcome measure is the difference in wound infection rates between the two randomized groups.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Patients older than 1-year of age, who presented to the ED with an uncomplicated soft-tissue laceration requiring repair.
Exclusion Criteria:
- Diabetes mellitus
- Asplenism
- primary immune disorder
- Mechanical heart valve
- Chronic alcoholism
- Steroid use,
- Antibiotics use
- Immunosuppressive chemotherapy
- Wounds older than 9 hours or from a human or animal bite
- Puncture wounds
- Wounds associated with bone, tendon, or neurovascular injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: wounds irrigated with sterile normal saline
Patients in this arm had their wounds irrigated with sterile normal saline
|
wounds were either irrigated with sterile normal saline or tap water.
|
Other: wound irrigation with tap water
Patients in the arm had their wounds irrigated with tap water
|
wounds were either irrigated with sterile normal saline or tap water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Infection at 48 hours
Time Frame: 48 hours
|
The primary outcome for this study is the difference in wound infection rates between the two randomized groups.
It is assessed at 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
wound infection manifest at 30 days
Time Frame: 30 days
|
patients are again contacted at 30 days after repair of their wound to assess for evidence of delayed or late infections
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M1272
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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